AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system… — Class II medical device recall Z-2667-2016
Terminated recall by Vision RT Ltd, reported 2016-08-31. Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended
| Recall number | Z-2667-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vision RT Ltd, London, United Kingdom |
| Recall initiated | 2016-06-30 |
| Classified | 2016-08-25 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2017-09-20 |
| Countries outside the US | CA, CH, DE, GB, JP, SE, TW |
| Quantity | 47 |
Product
AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.
Reason for recall
Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS]. 1. CRM 3194, No Serious Injury, No MDR, Aware date: Dec 11, 2015 2. CRM 3321, No Patient Involved, No MDR, Aware date: Jan 19, 2016 3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016 No patient harm was reported in any of these cases.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2667-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.